RE: Notice of Proposed Rulemaking; 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation: (RIN) 0906–AB19; (Vol. 83, No. 213, November 2, 2018)
On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, and our clinician partners – including more than 270,000 affiliated physicians, 2 million nurses and other caregivers – and the 43,000 health care leaders who belong to our professional membership groups, the American Hospital Association (AHA) appreciates the opportunity to comment on the Health Resources and Services Administration’s (HRSA) proposed rule to change the effective date to Jan. 1, 2019 for implementing final regulations regarding both the 340B Drug Pricing Program ceiling price, along with drug manufacturers’ civil monetary penalties (CMPs) for violations of the ceiling price, thereby ceasing any further delay. In addition, the final rule requires that HRSA make pricing information available to 340B hospitals and other participating providers online through a secure website.
The AHA supports HRSA’s implementation of the final rule, which, we believe, is critically important to the integrity of the 340B program. The repeated and lengthy delays in making the final rule effective have significantly harmed 340B hospitals and the low-income patients they serve, whom Congress intended to benefit from the 340B program. This is why AHA filed suit to assure that the rule would be finalized. The AHA is pleased that the Department of Health and Human Services (HHS) has abandoned its previous schedule and proposed to make the final rule effective on Jan. 1, 2019. The AHA strongly urges HRSA to meet the Jan. 1 effective date it has proposed. We also urge that the policy changes made by the final rule, first published in January 2017, remain substantially unchanged. Lastly, we urge HRSA to make the website available as soon as possible after the effective date, and under no circumstances any later than April 1, 2019 insomuch as the website is essential for effective enforcement of the 340B program.